Personalis to Present at the 4th Annual ICI Europe Summit 2018 in Berlin

On November 27, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming ICI Europe Summit 2018 in Berlin, Germany on Wednesday, November 28, 2018 at 9.30 AM, CET (Press release, Personalis, NOV 27, 2018, View Source [SID1234531655]).

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The presentation, entitled "Enabling Multidimensional Biomarker Discovery: Interrogating the Tumor, its Microenvironment, and Neoantigens with ACE ImmunoID," will discuss how the Personalis Platform overcomes the limitations associated with conventional NGS approaches that are used in translational research and the clinical development of new oncology therapeutics. The presentation will also introduce Personalis’ new ImmunoID NeXT Platform.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Erin Newburn, PhD, Associate Director, Field Applications Scientist

Bellicum Pharmaceuticals to Host Analyst and Investor Event and Webcast on Monday, December 3

On November 27, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that it will host an analyst and investor luncheon event and webcast on Monday, December 3, 2018 at 12:00 p.m. – 1:30 p.m. PST in San Diego, California (Press release, Bellicum Pharmaceuticals, NOV 27, 2018, View Source [SID1234531652]).

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The event will follow the Company’s key data presentations at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including interim analyses of the overall results from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial, a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. Featured speakers include Dr. Alice Bertaina, Associate Professor of Pediatrics (Stem Cell Transplantation), Lucile Packard Children’s Hospital at the Stanford School of Medicine, as well as Bellicum senior management.

A webcast replay of the event will be available on the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

UCL Spin-out Engitix Closes £5m Financing to Progress Liver Disease and Pancreatic Cancer Drug Discovery Platform and Pipeline

On November 27, 2018 Engitix Ltd, a company pioneering the development of both tissue-specific and disease-specific human extracellular matrix (ECM) for accelerating and improving the drug discovery process, reported it has closed a £5 million Series A financing, led by a private investor (Press release, Engitix, NOV 27, 2018, View Source [SID1234531649]).

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Engitix has validated its proprietary tissue-specific and disease-specific human ECM platform in determining drug efficacy in liver fibrosis through successful collaborations with a number of biotech and big pharma companies. With this new investment, the Company is now evolving its business model to in-house drug discovery, to develop a pipeline of candidate drugs targeting liver fibrosis and liver and pancreatic cancers.

Engitix was spun-out of the Institute for Liver and Digestive Health (ILDH), Division of Medicine, University College London (UCL) in 2016 by Dr Giuseppe Mazza, an inventor of decellularization protocols for human liver and other tissues, and Professor Massimo Pinzani, Director of ILDH and a world-renowned expert in the field of liver fibrosis. The Company acquired an exclusive license in 2017 from UCLB, UCL’s commercialisation company, to enabling ECM patents and other intellectual property.

The Company’s mission is to increase the efficacy and to the reduce cost of later stage drug failure by establishing more advanced platforms for drug target identification and validation in which healthy and diseased cells can be tested with potential therapeutic agents within their natural physiological and pathological microenvironment.

A key current limitation in developing more effective treatments in fibrosis and various solid cancers has been the failure to include human ECM in experimental models, with the majority of compounds failing in late stage clinical trials because of lack of efficacy.

The Company plans to double the size of its R&D team, recruiting at least an additional 10 scientists in London in the fields of drug discovery, bioinformatics and immune oncology, as well as establishing a presence in Boston, Massachusetts, USA.

Giuseppe Mazza, PhD, Co-Founder and Chief Executive Officer, said: "The traditional drug discovery process in fibrosis and solid tumours relies on artificial in vitro substrates and animal models. So far, these models have been shown to have limitations in providing efficient therapies for patients affected by these devastating diseases. The Engitix platform technology has already shown we can revolutionise our current understanding of human diseases while discovering more realistic targets for future drug development."

Steve Arlington, PhD, a Fellow of the Royal Society of Medicine, former Lead Global Partner, Life Sciences and Pharmaceuticals at PWC and recently appointed Chairman, said: "Engitix is developing a unique platform with many research applications, which allows the study of human pathophysiology leading to the discovery of novel targets and therapeutics that will benefit patients through the acceleration of drug discovery in liver disease and cancer."

Generex Biotechnology Signs Clinical Trial Agreement with the NSABP Foundation, Inc. for Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for Treatment of Triple-Negative Breast Cancer

On November 27, 2018 Generex Biotechnology Corporation (OTCMKTS:GNBT) reported that it has signed a clinical trial agreement (CTA) with the NSABP Foundation, Inc. (NSABP), to manage a Phase II clinical trial of Pembrolizumab (Keytruda) in combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer (Press release, Generex, NOV 27, 2018, View Source [SID1234531648]).

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The clinical trial, sponsored by Generex and conducted in conjunction with Merck, is currently being reviewed by the FDA, and clinical operations including site qualification, drug shipment and packaging, and IRB review and approval are underway, with plans to enroll patients in the first quarter of 2019.

Eric von Hofe, President of Generex’s wholly-owned subsidiary Antigen Express, commented, "We are very pleased to be working with the NSABP Foundation on this important trial combining AE37 and Keytruda in triple-negative breast cancer patients. The extensive expertise of the NSABP Foundation and their network of sites and investigators will be a great asset in this development effort."

Generex EVP of R&D Richard Purcell commented, "This contract with our research partners at the NSABP Foundation provides cost and timeline certainty to our AE37 development program in combination with Keytruda. We look forward to our continued collaboration with Merck and the NSABP Foundation research team."

Previously, the Company reported that it filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer.

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat cancer in women with certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but instead acts as a vaccine to activate the immune system to recognize the HER2 protein that is expressed on cancer cells as foreign.

AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response

BioClin Therapeutics Announces Name Change to Rainier Therapeutics

On November 27, 2018 BioClin Therapeutics, Inc., a privately-held clinical stage drug development company focused on helping patients in the high unmet need of bladder cancer, reported the company is changing its name to Rainier Therapeutics, Inc (Press release, BioClin Therapeutics, NOV 27, 2018, View Source [SID1234531647]).

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The new name, which will be implemented immediately, comes as the company prepares for late-stage, pivotal studies of its lead therapeutic candidate, vofatamab, which the company plans to initiate in 2019. Vofatamab (B-701) is an antibody specifically targeted against the FGFR3 receptor being developed for the treatment of patients in both early and late-stage bladder cancer.

"Our new logo incorporates the awe-inspiring image of a mountain and is designed to be symbolic for how we are striving to help our patients and caregivers, just as mountaineers strive to reach a summit. It also illustrates the challenging journey our patients face with this disease," commented Scott Myers, Chairman and CEO of Rainier Therapeutics. "We look forward to supporting late-stage clinical development efforts for vofatamab and are assembling an experienced, fully integrated team to provide support in multiple facets of operations."